PORTEFEUILLE

Cell and gene therapies (CGT) represent a revolution in personalised medicine. These ‘living drugs’ leverage the latest innovation in genetic engineering, and most advanced knowledge in immunology, leading to spectacular results in patients suffering from a variety of conditions. CAR T-cells are the most advanced CGT products and have the ability to cure cancer patients in a single dose. Over 1500 such cell-based therapies are currently in clinical trials, with the potential to save the lives of more than 3 million people annually. Unfortunately, most of these patients do not benefit, because at the moment, the entire industry only has the capacity to produce a few thousands doses each year. Industrial production of CAR T cell therapies relies on a tedious manual process that is, at least partly, responsible for prohibitive costs, typically half a million Swiss francs per patient. The widening range of indications and the resulting rapid increase in demand for clinical-grade cell products represent challenges that existing manufacturing processes and supply chain cannot address. Compact, closed and automated production units located directly at the hospitals represent a promising solution to unlock the transformative potential of these revolutionary treatments.

Our platform technology has the potential to catalyse the transition towards the widespread adoption of ex vivo gene edited cell therapies, such as CAR T cell therapies, and radically broaden the accessibility of these highly personalised cancer treatments. With our unique and innovative solution, we aim to increase overall safety and reproducibility of the manufacturing process by automating unnecessary manual steps; to remove the need for large sterile facilities that are expensive to build and maintain, and for long-distance cryogenic transport of fragile human samples; to lower the number of human operators and, as a consequence, significantly decrease the associated costs.

As of September 2022, Limula has successfully completed a POC on a functional prototype of its automated platform for the end-to-end production of CAR T-cell therapy. The company is now ready for its transition towards the industrialisation of its first product with private investment, while persuing critical R&D activities funded from additional non-dilutive sources. In parallel with prototyping activities, we have identified and engaged in conversations with strategic stakeholders across the value chain of Cell and Gene Therapy (CGT) in order to refine our value proposition and market entry strategy. We have received inputs from key opinion leaders active at all stages of the CGT life cycle, from early discovery in academic institutions to manufacturing of these therapies at scale. We have conducted structured interviews with potential customers across different segments to collect precise information about user requirement specifications (URS) for our platform technology in order to identify and develop additional critical functionalities that were initially not included in our initial development roadmap. With this information at hand, we have secured significant additional funding to continue the development of an enabling tool that meets the needs of the CGT industry.